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NCT Number: NCT07839689

Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome

The goal of this clinical trial is to learn if aerobic exercise training and connective tissue massage, in addition to patient education, can help treat women with bladder pain syndrome. The main questions it aims to answer are:

Does aerobic exercise training and connective tissue massage reduce bladder-related pain severity?

Does this intervention improve urinary symptoms, pain sensitivity, central sensitization-related symptoms, psychological symptoms, and quality of life?

Researchers will compare patient education plus aerobic exercise training and connective tissue massage with patient education alone to see if the combined physiotherapy program is more effective.

Participants will:

Receive patient education about bladder pain syndrome

Be randomly assigned to one of two groups

Receive either patient education alone or patient education together with aerobic exercise training and connective tissue massage for 8 weeks

Complete assessments at the beginning of the study and after 8 weeks

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female individuals aged 18 years or older
  • Diagnosis of bladder pain syndrome
  • Bladder-related pain, discomfort, and/or burning symptoms lasting for at least 6 months
  • Bladder-related symptom severity, including pain, discomfort, and/or burning, of at least 3 cm on the Visual Analog Scale during the last week
  • Receiving stable medical treatment
  • Being medically suitable for moderate-intensity aerobic exercise according to the Physical Activity Readiness Questionnaire
  • Volunteering to participate in the study and signing the informed consent form
  • For individuals aged 65 years or older, a Mini-Mental State Examination score of 24 or higher

Exclusion criteria

  • Presence of acute urinary tract or urogynecological infection
  • Pregnancy and/or breastfeeding
  • Diagnosis of pelvic, urological, and/or gynecological malignancy or history of pelvic radiotherapy
  • Pelvic or abdominal surgery within the last 6 months
  • Presence of congenital urinary system anomalies
  • History of neurological disease or diagnosis of neurogenic bladder
  • Open wound or active skin infection in the area where manual therapy will be applied

Treatment and study plan

Patient education

Behavioral

Participants will receive patient education about bladder pain syndrome, symptom management, lifestyle recommendations, and strategies to support self-management. This intervention will be provided to both study groups.

Aerobic Exercise Training

Behavioral

Participants in the intervention group will receive an 8-week aerobic exercise training program in addition to patient education.

Connective Tissue Massage

Other

Participants in the intervention group will receive connective tissue massage in addition to patient education and aerobic exercise training. The intervention will be delivered by a physiotherapist according to the study protocol as part of the 8-week multimodal physiotherapy program.

Primary outcomes

  1. Change in Bladder-Related Pain Severity

    Time frame: Baseline and 8 weeks

    Bladder-related pain severity will be assessed using a 10-cm Visual Analog Scale. Participants will be asked to mark the point that best represents the most severe bladder-related pain or pain-like discomfort, such as burning, pressure, or discomfort, experienced during the last three days. Scores range from 0 to 10, with higher scores indicating greater pain severity.

Secondary outcomes

  1. Change in Bladder Pain Syndrome-Related Symptom Severity

    Time frame: Baseline and 8 weeks

    Bladder pain syndrome-related symptom severity will be assessed using the Interstitial Cystitis Symptom Index. The index consists of 4 items assessing urinary urgency, urinary frequency, nocturia, and bladder pain or burning. Total scores range from 0 to 20, with higher scores indicating greater bladder pain syndrome-related symptom severity.

  2. Change in Bladder Pain Syndrome-Related Problem Severity

    Time frame: Baseline and 8 weeks

    Bladder pain syndrome-related problem severity will be assessed using the Interstitial Cystitis Problem Index. The index consists of 4 items assessing the extent to which urinary frequency, nocturia, urinary urgency, and bladder pain or burning are experienced as problems. Total scores range from 0 to 16, with higher scores indicating greater bladder pain syndrome-related problem severity.

  3. Change in Pressure Pain Threshold

    Time frame: Baseline and 8 weeks

    Pressure pain threshold will be assessed using a digital pressure algometer over the suprapubic region, peroneal region, and ulnar surface of the forearm. The value at which the participant first perceives the applied pressure as painful will be recorded. Three measurements will be taken from each site.

  4. Change in Conditioned Pain Modulation

    Time frame: Baseline and 8 weeks

    Conditioned pain modulation will be assessed using pressure pain threshold measurement over the upper trapezius muscle as the test stimulus and a cuff pressure test applied to the contralateral upper extremity as the conditioning stimulus. Pressure pain threshold will be measured before and immediately after the conditioning stimulus.

  5. Change in Central Sensitization-Related Symptoms

    Time frame: Baseline and 8 weeks

    Central sensitization-related symptoms will be assessed using the Central Sensitization Inventory. The scale includes 25 items related to symptoms such as pain, fatigue, sleep disturbance, cognitive complaints, and emotional symptoms. Total scores range from 0 to 100, with higher scores indicating greater central sensitization-related symptom burden.

  6. Change in Anxiety and Depression Symptoms

    Time frame: Baseline and 8 weeks

    Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale. The scale consists of 14 items and includes two 7-item subscales evaluating anxiety and depression. Scores for each subscale range from 0 to 21, with higher scores indicating greater anxiety or depression symptom severity.

  7. Change in Functional Exercise Capacity

    Time frame: Baseline and 8 weeks

    Functional exercise capacity will be assessed using the 6-Minute Walk Test. Participants will be asked to walk as far as possible without running for 6 minutes in a suitable corridor. The total distance walked will be recorded in meters.

  8. Change in Health-Related Quality of Life

    Time frame: Baseline and 8 weeks

    Health-related quality of life will be assessed using the 12-Item Short Form Health Survey. The questionnaire yields Physical Component Summary and Mental Component Summary scores. Each score ranges from 0 to 100, with higher scores indicating better physical or mental health-related quality of life.

  9. Subjective Perception of Change in Bladder-Related Pain Symptoms

    Time frame: At 8 weeks

    Participants' perceived change in bladder-related pain symptoms compared with the beginning of treatment will be assessed using a 7-point subjective perception of change scale. Scores range from 1 to 7, where 1 indicates markedly worse, 4 indicates no change, and 7 indicates markedly improved. Higher scores indicate greater perceived improvement.

  10. Adherence to Exercise and Intervention

    Time frame: During the 8-week intervention period

    Adherence to the intervention will be assessed based on attendance at clinical sessions and continuation of out-of-clinic aerobic exercises. Attendance at clinical sessions will be recorded after each session. Adherence to out-of-clinic aerobic exercises will be monitored using exercise diaries kept by participants and the physiotherapist, and adherence will be calculated as a percentage.

  11. Adherence to Lifestyle Recommendations

    Time frame: At 8 weeks

    Adherence to lifestyle recommendations will be assessed using a Numeric Rating Scale. Participants will be asked to rate their overall adherence to the lifestyle recommendations on a scale from 0 to 10, where 0 indicates no adherence and 10 indicates complete adherence.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Effects of Aerobic Exercise Training and Connective Tissue Massage in Individuals With Bladder Pain Syndrome

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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